Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01923181
First received: August 13, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: oral placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects who achieve (yes/no) HbA1c below 7 percent (53 mmol/mol) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in body mass index (BMI) [ Time Frame: week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: Weeks 0-31 ] [ Designated as safety issue: No ]
  • Number of confirmed hypoglycaemic episodes recorded [ Time Frame: Weeks 0-31 ] [ Designated as safety issue: No ]

Estimated Enrollment: 603
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:Semaglutide tablets : 2.5 mg
2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 2:Semaglutide tablets: 2.5 mg/5 mg
2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 3:Semaglutide tablets: 5.0 mg/10 mg
5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 4:Semaglutide tablets:5.0 mg/10 mg/20 mg
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks.

All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-daily oral administration as tablets.
Experimental: 7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks.

All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Drug: semaglutide
Once-daily oral administration as tablets.
Placebo Comparator: 8:Placebo tablets
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: oral placebo
Once-daily oral administration as tablets.
Active Comparator: 9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Drug: semaglutide
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI above or equal to 25 and below or equal to 40 kg/m^2
  • Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
  • HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Chronic malabsorption, regardless of aetiology
  • History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923181

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Tucson, Arizona, United States, 85712
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
Novo Nordisk Clinical Trial Call Center
Long Beach, California, United States, 90806
Novo Nordisk Clinical Trial Call Center
Poway, California, United States, 92064
Novo Nordisk Clinical Trial Call Center
Santa Ana, California, United States, 92705
Novo Nordisk Clinical Trial Call Center
Spring Valley, California, United States, 91978
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80904
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80220
United States, Florida
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33014
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
Novo Nordisk Clinical Trial Call Center
South Miami, Florida, United States, 33143
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Athens, Georgia, United States, 30606
Novo Nordisk Clinical Trial Call Center
Conyers, Georgia, United States, 30094-5965
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Addison, Illinois, United States, 60101
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60634
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Wichita, Kansas, United States, 67203
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89109
United States, New York
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10001
Novo Nordisk Clinical Trial Call Center
Rochester, New York, United States, 14609
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28803
Novo Nordisk Clinical Trial Call Center
Raleigh, North Carolina, United States, 27609
Novo Nordisk Clinical Trial Call Center
Salisbury, North Carolina, United States, 28144
United States, North Dakota
Novo Nordisk Clinical Trial Call Center
Fargo, North Dakota, United States, 58103-6413
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Jersey shore, Pennsylvania, United States, 17740
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19140
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19147
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Moncks Corner, South Carolina, United States, 29461
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Humboldt, Tennessee, United States, 38343
Novo Nordisk Clinical Trial Call Center
Spring Hill, Tennessee, United States, 37174
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78209
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23502
United States, Washington
Novo Nordisk Clinical Trial Call Center
Wenatchee, Washington, United States, 98801-2028
Austria
Graz, Austria, 8036
Bulgaria
Sofia, Bulgaria, 1431
Canada, New Brunswick
Bathurst, New Brunswick, Canada, E2A 4Z9
Denmark
Århus C, Denmark, 8000
Germany
Hamburg, Germany, 22607
Israel
Beer Sheva, Israel, 84101
Italy
Roma, Italy, 00161
Malaysia
Kota Bharu, Malaysia, 15000
Serbia
Belgrade, Serbia, 11000
South Africa
Port Elizabeth, Eastern Cape, South Africa, 6045
Spain
Sevilla, Spain, 41003
Sweden
Karlstad, Sweden, 651 85
United Kingdom
London, United Kingdom, W6 7HY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01923181     History of Changes
Other Study ID Numbers: NN9924-3790, 2012-004994-16, U1111-1136-4716
Study First Received: August 13, 2013
Last Updated: April 24, 2014
Health Authority: Austria: Agency for Health and Food Safety
Bulgaria: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: Ministry of Health
Malaysia: Ministry of Health
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014